NCT03493854 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer · Source last updated 2024-06-26

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse events (AEs): From first dose of study treatment until 28 days after last dose of study treatment (up to 1 year, 6 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 4 years, 11 months)
Other-event reporting threshold: 5%

After initiation of study drug, all AEs were reported until 28 days after the last dose of study drug. After this period, only drug-related serious AEs, heart failure, pregnancies, and malignancies were reported.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor \[G-CSF\] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.	52 / 252	251 / 252	12 / 252
Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.	49 / 248	248 / 248	14 / 248

Group identifiers: EG000: Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy · EG001: Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
1
num At Risk
252
num Events
1
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
10
num At Risk
252
num Events
11
group Id
EG001
num Affected
9
num At Risk
248
num Events
9
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
1
num At Risk
252
num Events
1
group Id
EG001
num Affected
0
num At Risk
248
num Events
0
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
3
num At Risk
252
num Events
3
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
0
num At Risk
252
num Events
0
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
0
num At Risk
252
num Events
0
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
6
num At Risk
252
num Events
6
group Id
EG001
num Affected
4
num At Risk
248
num Events
5
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
0
num At Risk
252
num Events
0
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
1
num At Risk
252
num Events
1
group Id
EG001
num Affected
0
num At Risk
248
num Events
0
term
Goitre
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
0
num At Risk
252
num Events
0
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
0
num At Risk
252
num Events
0
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Anal incontinence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
1
num At Risk
252
num Events
1
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Colitis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
109
num At Risk
252
num Events
148
group Id
EG001
num Affected
90
num At Risk
248
num Events
117
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
36
num At Risk
252
num Events
58
group Id
EG001
num Affected
25
num At Risk
248
num Events
42
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
64
num At Risk
252
num Events
119
group Id
EG001
num Affected
58
num At Risk
248
num Events
109
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
9
num At Risk
252
num Events
11
group Id
EG001
num Affected
14
num At Risk
248
num Events
14
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
14
num At Risk
252
num Events
15
group Id
EG001
num Affected
14
num At Risk
248
num Events
15
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
15
num At Risk
252
num Events
17
group Id
EG001
num Affected
22
num At Risk
248
num Events
29
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
21
num At Risk
252
num Events
25
group Id
EG001
num Affected
20
num At Risk
248
num Events
31
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
54
num At Risk
252
num Events
79
group Id
EG001
num Affected
57
num At Risk
248
num Events
75
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
148
num At Risk
252
num Events
309
group Id
EG001
num Affected
152
num At Risk
248
num Events
293
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
31
num At Risk
252
num Events
34
group Id
EG001
num Affected
35
num At Risk
248
num Events
42
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
5
num At Risk
252
num Events
6
group Id
EG001
num Affected
13
num At Risk
248
num Events
14
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
11
num At Risk
252
num Events
11
group Id
EG001
num Affected
22
num At Risk
248
num Events
22
term
Haemorrhoids

Complete source fields

description

event Groups

deaths Num Affected
12
deaths Num At Risk
252
description
Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks (Q2W) (given with granulocyte colony-stimulating factor \[G-CSF\] support as needed according to local guidelines) followed by paclitaxel QW for 12 weeks; or 2) 4 cycles of doxorubicin plus cyclophosphamide (AC) once every 3 weeks (Q3W) followed by docetaxel Q3W for 4 cycles. Pertuzumab and trastuzumab were given intravenously (IV) for 4 cycles Q3W concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of pertuzumab IV and trastuzumab IV for a total of 18 cycles.
id
EG000
other Num Affected
251
other Num At Risk
252
serious Num Affected
52
serious Num At Risk
252
title
Arm A: Pertuzumab IV + Trastuzumab IV + Chemotherapy
deaths Num Affected
14
deaths Num At Risk
248
description
Participants received 8 cycles of investigator's choice of neoadjuvant chemotherapy. This included either: 1) 4 cycles of ddAC Q2W (given with G-CSF support as needed according to local guidelines) followed by paclitaxel once every week (QW) for 12 weeks; or 2) 4 cycles of AC Q3W followed by docetaxel Q3W for 4 cycles. The fixed-dose combination (FDC) of pertuzumab and trastuzumab was given subcutaneously (SC) for 4 cycles (Q3W) concurrently with the taxane component of chemotherapy. After completing their neoadjuvant therapy, participants underwent surgery. Thereafter, participants received an additional 14 cycles of the FDC of pertuzumab and trastuzumab SC for a total of 18 cycles.
id
EG001
other Num Affected
248
other Num At Risk
248
serious Num Affected
49
serious Num At Risk
248
title
Arm B: Pertuzumab and Trastuzumab FDC SC + Chemotherapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
109
num At Risk
252
num Events
148
group Id
EG001
num Affected
90
num At Risk
248
num Events
117
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
36
num At Risk
252
num Events
58
group Id
EG001
num Affected
25
num At Risk
248
num Events
42
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
64
num At Risk
252
num Events
119
group Id
EG001
num Affected
58
num At Risk
248
num Events
109
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
9
num At Risk
252
num Events
11
group Id
EG001
num Affected
14
num At Risk
248
num Events
14
term
Dry eye
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
14
num At Risk
252
num Events
15
group Id
EG001
num Affected
14
num At Risk
248
num Events
15
term
Lacrimation increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
15
num At Risk
252
num Events
17
group Id
EG001
num Affected
22
num At Risk
248
num Events
29
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
21
num At Risk
252
num Events
25
group Id
EG001
num Affected
20
num At Risk
248
num Events
31
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
54
num At Risk
252
num Events
79
group Id
EG001
num Affected
57
num At Risk
248
num Events
75
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
148
num At Risk
252
num Events
309
group Id
EG001
num Affected
152
num At Risk
248
num Events
293
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
31
num At Risk
252
num Events
34
group Id
EG001
num Affected
35
num At Risk
248
num Events
42
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
5
num At Risk
252
num Events
6
group Id
EG001
num Affected
13
num At Risk
248
num Events
14
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
11
num At Risk
252
num Events
11
group Id
EG001
num Affected
22
num At Risk
248
num Events
22
term
Haemorrhoids

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
1
num At Risk
252
num Events
1
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
10
num At Risk
252
num Events
11
group Id
EG001
num Affected
9
num At Risk
248
num Events
9
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
1
num At Risk
252
num Events
1
group Id
EG001
num Affected
0
num At Risk
248
num Events
0
term
Immune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
3
num At Risk
252
num Events
3
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
0
num At Risk
252
num Events
0
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
0
num At Risk
252
num Events
0
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
6
num At Risk
252
num Events
6
group Id
EG001
num Affected
4
num At Risk
248
num Events
5
term
Cardiac failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
0
num At Risk
252
num Events
0
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
1
num At Risk
252
num Events
1
group Id
EG001
num Affected
0
num At Risk
248
num Events
0
term
Goitre
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
0
num At Risk
252
num Events
0
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
0
num At Risk
252
num Events
0
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Anal incontinence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA version 26.0
stats
group Id
EG000
num Affected
1
num At Risk
252
num Events
1
group Id
EG001
num Affected
1
num At Risk
248
num Events
1
term
Colitis

time Frame

Adverse events (AEs): From first dose of study treatment until 28 days after last dose of study treatment (up to 1 year, 6 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 4 years, 11 months)

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